Trial Outcomes & Findings for Metformin for the Prevention of Episodic Migraine (MPEM) (NCT NCT02593097)
NCT ID: NCT02593097
Last Updated: 2020-07-01
Results Overview
Total number of moderate and severe headache days
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
Baseline through end of study for a total of approximately 32 weeks
Results posted on
2020-07-01
Participant Flow
Participant milestones
| Measure |
Metformin First, Then Matching Placebo
Subjects who received Metformin in either the first or last 12 weeks of the study
Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
Matching Placebo First, Then Metformin
Subjects who received matching placebo either the first or last 12 weeks of the study
Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
|---|---|---|
|
First Intervention (12 Weeks)
STARTED
|
14
|
20
|
|
First Intervention (12 Weeks)
Received Intervention
|
14
|
20
|
|
First Intervention (12 Weeks)
COMPLETED
|
12
|
16
|
|
First Intervention (12 Weeks)
NOT COMPLETED
|
2
|
4
|
|
Washout (4 Weeks)
STARTED
|
12
|
16
|
|
Washout (4 Weeks)
COMPLETED
|
12
|
16
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (12 Weeks)
STARTED
|
12
|
16
|
|
Second Intervention (12 Weeks)
COMPLETED
|
9
|
15
|
|
Second Intervention (12 Weeks)
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Metformin First, Then Matching Placebo
Subjects who received Metformin in either the first or last 12 weeks of the study
Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
Matching Placebo First, Then Metformin
Subjects who received matching placebo either the first or last 12 weeks of the study
Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
|---|---|---|
|
First Intervention (12 Weeks)
Lost to Follow-up
|
1
|
2
|
|
First Intervention (12 Weeks)
Withdrawal by Subject
|
1
|
2
|
|
Second Intervention (12 Weeks)
Lost to Follow-up
|
1
|
1
|
|
Second Intervention (12 Weeks)
Lack of Efficacy
|
1
|
0
|
|
Second Intervention (12 Weeks)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metformin First, Then Matching Placebo
n=14 Participants
Subjects who received Metformin in either the first or last 12 weeks of the study
Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
Matching Placebo First, Then Metformin
n=20 Participants
Subjects who received matching placebo either the first or last 12 weeks of the study
Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.
Metformin: Metformin 500mg twice daily
Matching Placebo: Matching Placebo twice daily
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.85 years
STANDARD_DEVIATION 6.91 • n=14 Participants
|
46.83 years
STANDARD_DEVIATION 10.94 • n=20 Participants
|
45.34 years
STANDARD_DEVIATION 8.92 • n=34 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=14 Participants
|
17 Participants
n=20 Participants
|
28 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
20 participants
n=20 Participants
|
34 participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study for a total of approximately 32 weeksPopulation: Data was only analyzed for the subjects that completed both interventions.
Total number of moderate and severe headache days
Outcome measures
| Measure |
Metformin
n=30 Participants
Subjects who received Metformin in either the first or last 12 weeks of the study
|
Matching Placebo
n=32 Participants
Subjects who received matching placebo either the first or last 12 weeks of the study
|
|---|---|---|
|
Headache Days
|
23.64 Days
Standard Deviation 2.15
|
24.33 Days
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data was not collected for the matching placebo arm. This outcome measure was specific for metformin, no analysis was done for the placebo.
Percentage of patients whose migraines reduced by at least 50% on Metformin.
Outcome measures
| Measure |
Metformin
n=30 Participants
Subjects who received Metformin in either the first or last 12 weeks of the study
|
Matching Placebo
Subjects who received matching placebo either the first or last 12 weeks of the study
|
|---|---|---|
|
Greater Than >50% Reduction in Migraine Days on Metformin
|
10.1 percentage of subjects
Interval -3.46 to 23.66
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study for a total of approximately 32 weeksPopulation: Data was only analyzed for the subjects that completed both interventions.
Total number of subjects with treatment-related adverse events
Outcome measures
| Measure |
Metformin
n=30 Participants
Subjects who received Metformin in either the first or last 12 weeks of the study
|
Matching Placebo
n=32 Participants
Subjects who received matching placebo either the first or last 12 weeks of the study
|
|---|---|---|
|
Adverse Events
|
3 Participants
|
1 Participants
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=30 participants at risk
Subjects who received Metformin in either the first or last 12 weeks of the study
|
Matching Placebo
n=32 participants at risk
Subjects who received matching placebo either the first or last 12 weeks of the study
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dry Mouth
|
10.0%
3/30 • Number of events 3 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • Number of events 3 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
|
Skin and subcutaneous tissue disorders
Dry hair
|
10.0%
3/30 • Number of events 3 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
10.0%
3/30 • Number of events 3 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks
Safety population included all participants who received at least one dose of intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place